COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S036 · decided 2008-08-27
Approval details
- PMA number
- P000025
- Supplement
- S036
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2008-06-27
- Decision date
- 2008-08-27
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN INNSBRUCK, AUSTRIA.
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